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AzTrials

Asherman's SyndromePhase 4BMSCTNCT02144987

Bone Marrow Stem Cell Treatment for Asherman's Syndrome and Endometrial Atrophy

A Phase 4 study testing Bone Marrow CD133+ Stem Cell Transplantation in people with Asherman's Syndrome and Endometrium; Atrophy, Cervix, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether Bone Marrow Stem Cell transplantation may improve Assisted Reproduction Techniques (ART) outcomes in refractive Asherman's Syndrome or Atrophic Endometrium. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
Bone Marrow CD133+ Stem Cell Transplantation
How many people
16 participants
Where
2 sitesSpain
Study dates
Apr 2013to Sep 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients diagnosed of Asherman Syndrome and absence of pregnancy after treatment
  • Endometrial atrophy (<6mm) with Implantation Failure
  • Age 20-45 years-old
  • Normal liver, heart and kidney function
  • Presence of menstrual bleeding with Natural Cycle or HRT
  • Absence of psychiatric pathology and ability to accomplish the treatment
  • β-hCG negative
  • Absence of SDT

Who cannot join

  • Absence of peripheral vein access
  • Lack of accomplish inclusion criteria

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Clinico y Universitario de Valencia

    Valencia, Valencia, 46010

  • Instituto Valenciano Infertilidad

    Valencia, Valencia, 46015

Other trials in Spain

About this study

Official title: New Therapeutic Approaches to Treat Asherman's Syndrome and Endometrial Atrophy Based in BM Stem Cells Autologous Transplantation

The purpose of this study is to determine whether Bone Marrow Stem Cell transplantation may improve Assisted Reproduction Techniques (ART) outcomes in refractive Asherman's Syndrome or Atrophic Endometrium.

Read the detailed description

This novel technique refers to the use of CD133+ autologous bone marrow stem-cells to regenerate the endometrium in patients with Asherman's Syndrome, Endometrial Atrophy or any condition that produce a destruction of the endometrium or its de novo creation in a bioengineered uterus.

It requires a previous mobilization in the peripheral blood of CD133+ autologous bone marrow stem cells, subsequent apheresis and transplant of the same cells in the spiral arterioles of the uterus with the aim to regenerate de novo the endometrium. This technique represents a new therapeutical approach for the treatment of endometrial regeneration problems such Asherman Syndrome and the endometrial atrophy since currently no specific treatment for these endometrial pathologies exist.

A prospective experimental non controlled study has been designed in order to assess the effectiveness of these technique as a new tool for treat Asherman's Syndrome and Endometrial Atrophy.

Being tested
Bone Marrow CD133+ Stem Cell Transplantation
Medical subject headings
Gynatresia, Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bone Marrow CD133+ Stem Cell TransplantationBiological

    Also called Neupogen

    1. Bone Marrow Stem Cell (BMSC) mobilization peripheral blood induced by granulocyte-CSF (G-CSF) 5 mcg/kg sc every 12 hours for 4 days.
    2. BMSC recollection with apheresis procedure and positive selection of the CD133+ cells. The selection procedure will be performed for a maximum of 3 hours or until at least 50 million cells are collected.
    3. CD133+ cells transplantation into the uterine spiral arterioles by intra-arterial catheterization
    4. Subsequently Hormonal Replacement Therapy (HRT) will be given to the patients
    5. Hysteroscopy will be performed 2-3 months after stem cell transplantation
    6. Embryo transfer will be performed 3-6 months after stem cell transplantation with HRT endometrial preparation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live-birth rate

    Live birth rate is the percentage of all cycles that lead to live birth, and is the pregnancy rate adjusted for miscarriages and stillbirths.

    Measured: 15 months

  2. Ongoing pregnancy rate

    Ongoing pregnancy rate is the percentage of all cycles that lead to presence of heartbeat in Ultrasound scan at the end of the first trimester

    Measured: 9 months

  3. Implantation Rate

    Implantation rate is the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period.

    Measured: 6 months

Secondary outcomes (2)

  1. Endometrial thickness prior to the treatment

    Endometrial thickness measured with Ultrasound in a previous treatment with Hormonal Replacement Therapy

    Measured: 0

  2. Endometrial Thickness after treatment

    Endometrial thickness measured with Ultrasound with Hormonal Replacement Therapy 3-6 months after Bone Marrow Stem Cell Transplantation

    Measured: 3-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2014 (estimated)
  2. Study startApr 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02144987
Sponsor's protocol ID
1101-C-092-JS
Acronym
BMSCT
Status last verified
Apr 2015
First submitted
19 May 2014
Last updated
22 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Chan RW, Schwab KE, Gargett CE. Clonogenicity of human endometrial epithelial and stromal cells. Biol Reprod. 2004 Jun;70(6):1738-50. doi: 10.1095/biolreprod.103.024109. Epub 2004 Feb 6.

    PubMed 14766732

  • Cervello I, Gil-Sanchis C, Mas A, Faus A, Sanz J, Moscardo F, Higueras G, Sanz MA, Pellicer A, Simon C. Bone marrow-derived cells from male donors do not contribute to the endometrial side population of the recipient. PLoS One. 2012;7(1):e30260. doi: 10.1371/journal.pone.0030260. Epub 2012 Jan 19.

    PubMed 22276168

  • Ikoma T, Kyo S, Maida Y, Ozaki S, Takakura M, Nakao S, Inoue M. Bone marrow-derived cells from male donors can compose endometrial glands in female transplant recipients. Am J Obstet Gynecol. 2009 Dec;201(6):608.e1-8. doi: 10.1016/j.ajog.2009.07.026. Epub 2009 Oct 3.

    PubMed 19800602

  • Taylor HS. Endometrial cells derived from donor stem cells in bone marrow transplant recipients. JAMA. 2004 Jul 7;292(1):81-5. doi: 10.1001/jama.292.1.81.

    PubMed 15238594

  • Cervello I, Mas A, Gil-Sanchis C, Peris L, Faus A, Saunders PT, Critchley HO, Simon C. Reconstruction of endometrium from human endometrial side population cell lines. PLoS One. 2011;6(6):e21221. doi: 10.1371/journal.pone.0021221. Epub 2011 Jun 21.

    PubMed 21712999

  • Nagori CB, Panchal SY, Patel H. Endometrial regeneration using autologous adult stem cells followed by conception by in vitro fertilization in a patient of severe Asherman's syndrome. J Hum Reprod Sci. 2011 Jan;4(1):43-8. doi: 10.4103/0974-1208.82360.

    PubMed 21772740

  • March CM. Management of Asherman's syndrome. Reprod Biomed Online. 2011 Jul;23(1):63-76. doi: 10.1016/j.rbmo.2010.11.018. Epub 2010 Dec 4.

    PubMed 21549641

  • Zhang X, Chen CH, Confino E, Barnes R, Milad M, Kazer RR. Increased endometrial thickness is associated with improved treatment outcome for selected patients undergoing in vitro fertilization-embryo transfer. Fertil Steril. 2005 Feb;83(2):336-40. doi: 10.1016/j.fertnstert.2004.09.020.

    PubMed 15705371

  • Sanz-Ruiz R, Gutierrez Ibanes E, Arranz AV, Fernandez Santos ME, Fernandez PL, Fernandez-Aviles F. Phases I-III Clinical Trials Using Adult Stem Cells. Stem Cells Int. 2010 Nov 4;2010:579142. doi: 10.4061/2010/579142.

    PubMed 21076533

  • Makela J, Anttila V, Ylitalo K, Takalo R, Lehtonen S, Makikallio T, Niemela E, Dahlbacka S, Tikkanen J, Kiviluoma K, Juvonen T, Lehenkari P. Acute homing of bone marrow-derived mononuclear cells in intramyocardial vs. intracoronary transplantation. Scand Cardiovasc J. 2009 Dec;43(6):366-73. doi: 10.1080/14017430903045350.

    PubMed 19544220

  • Santamaria X, Cabanillas S, Cervello I, Arbona C, Raga F, Ferro J, Palmero J, Remohi J, Pellicer A, Simon C. Autologous cell therapy with CD133+ bone marrow-derived stem cells for refractory Asherman's syndrome and endometrial atrophy: a pilot cohort study. Hum Reprod. 2016 May;31(5):1087-96. doi: 10.1093/humrep/dew042. Epub 2016 Mar 22.

    PubMed 27005892

  • Cervello I, Gil-Sanchis C, Santamaria X, Cabanillas S, Diaz A, Faus A, Pellicer A, Simon C. Human CD133(+) bone marrow-derived stem cells promote endometrial proliferation in a murine model of Asherman syndrome. Fertil Steril. 2015 Dec;104(6):1552-60.e1-3. doi: 10.1016/j.fertnstert.2015.08.032. Epub 2015 Sep 15.

    PubMed 26384164

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bone Marrow CD133+ Stem Cell Transplantation in people with Asherman's Syndrome and Endometrium; Atrophy, Cervix, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live-birth rate (time frame: 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02144987, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.

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